Phase 2
Completed N=491
Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes
Source: ClinicalTrials.gov NCT01012037 ↗Enrolled (actual)
491
Serious AEs
2.9%
Results posted
Oct 2011
Primary outcomePrimary: HbA1c Change From Baseline at Week 12 — 0.28; -0.46; -0.52 percent — p=<0.0001
Summary
The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline at Week 12 |
0.28; -0.46; -0.52 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis |
0.32; -0.34; -0.34 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis |
0.27; -0.51; -0.55 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 12 |
-3.5; -17.2; -21.3 | 0.0029 sig |
| SECONDARY FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis |
-1.2; -17.8; -20.1 | 0.0002 sig |
| SECONDARY FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis |
-8.7; -18.7; -23.9 | 0.0653 |
| SECONDARY Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12 |
16.3; 55.1; 59.7 | — |
| SECONDARY Percentage of Patients With Rescue Therapy |
7.0; 3.7; 1.8 | — |
| SECONDARY The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment |
10.0; 34.0; 33.0 | — |
| SECONDARY The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment |
0.0; 12.7; 11.8 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of type 2 diabetes mellitus.
- Current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. Metformin must be administered in twice daily dosing regimen. Patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
- Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
- Body Mass Index (BMI) 240 mg/dL or 13.3 mmol/L).
- Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
- Impaired hepatic or renal function, or gastric bypass surgery.
- Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
- Current treatment with systemic steroids or change in dosage of thyroid hormones.
- Alcohol or drug abuse within 3 months of informed consent.
- Participation in another trial with investigational drug within 2 months prior to informed consent.
- Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.
Data sourced from ClinicalTrials.gov (NCT01012037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.